EM Quality Associate Specialist Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Environmental Monitoring (EM) Quality Associate Specialist provides direct Quality support to production areas as part of the Live Virus Vaccine organization. The EM Quality Associate Specialist, with guidance from the EM Quality Senior Specialists and EM Quality Lead, will execute tasks associated with deviation management, environmental monitoring projects, sterility assurance and environmental control initiatives at the site. The EM Quality Associate Specialist will become knowledgeable in regulatory agency requirements and cGMPs to ensure that all areas maintain adherence to compliance standards and maintain environmental control. Job functions are performed both on the production shop floor and in an office environment. Specific responsibilities include but are not limited to the following:
- Execute assignments that focus on deviation management, sample collection, continuous improvement, environmental control, standardization of business processes and compliance.
- Collaborate with members from other support groups within the organizations, such as Operations, Technology, and Quality, in the identification and implementation of continuous improvement initiatives and action plans.
- Author environmental monitoring documents, protocols, reports and/or investigative studies
- Perform data analysis of environmental monitoring data
- Participate in Go-Sees in collaborations with Operations, Technology, and/or IPT Quality
Education Minimum Requirement:
- Bachelor’s degree in microbiology, molecular biology, biochemistry, biology, or biological engineering or related science /engineering field with solid academic record and/or relevant work experience.
Required Experience and Skills:
- Evidence of leadership skills coupled with good oral and written communication skills.
- Evidence of problem-solving and data analysis skills
- Ability to work in a team environment
Preferred Experience and Skills:
- Work experience in a laboratory, technology, manufacturing, or quality position
- Knowledge of aseptic processing operations, vaccine and/or pharmaceutical processing
- Understanding of cGMPs as they apply to the pharmaceutical industry and/or a related industries.
- Experience in environmental monitoring or environmental control
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Assoc. Spclst, Quality
Primary Location: NA-United States
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
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